Winfuran: Withdrawal of the marketing authorisation application

nalfurafine

Overview

On 17 January 2014, Toray International U.K. Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Winfuran, intended for the treatment of severe uraemic pruritus (a form of itching) in patients with end-stage kidney disease on dialysis.

  • List item

    Withdrawal of the marketing authorisation application for Winfuran (nalfurafine) (PDF/88.88 KB)


    First published: 24/01/2014
    Last updated: 24/01/2014
    EMA/33514/2014

  • Key facts

    Name
    Winfuran
    Product number
    EMEA/H/C/002683
    International non-proprietary name (INN) or common name
    • nalfurafine
    Active substance
    • nalfurafine
    Date of withdrawal
    17/01/2014
    Company making the application
    Toray International U.K. Limited
    Withdrawal type
    Initial authorisation

    All documents

    Related information on withdrawals

    A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter (withdrawal letter Doc. type, leave the 'Author' in properties blank).

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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